Adult: In patients on haemodialysis or peritoneal dialysis, or for those not requiring dialysis: As sevelamer carbonate or sevelamer hydrochloride: Initially, 800-1,600 mg tid. Dose should be initiated based on serum phosphorus level: >5.5-<7.5 mg/dL: 800 mg tid; ≥7.5 mg/dL: 1,600 mg tid. Adjust the dose gradually by 800 mg tid increment every 2-4 weeks until achieving the desired serum phosphorus levels. Treatment and dosing recommendations may vary among individual products and between countries (refer to specific product guidelines). Child: As sevelamer carbonate: ≥6 years BSA ≥0.75-<1.2 m2: 800 mg tid, titrate by 400 mg tid every 2-4 weeks as necessary; BSA ≥1.2 m2: 1,600 mg tid, titrate by 800 mg tid every 2-4 weeks as necessary. Treatment and dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Administration
Should be taken with food.
Reconstitution
Powder for oral susp: Disperse the contents of each 800 mg sachet in 30 mL of water and each 2,400 mg sachet in 60 mL of water. Instruction for reconstitution may vary among local guidelines (refer to specific country guidelines).
Contraindications
Hypophosphataemia, bowel obstruction.
Special Precautions
Patient with dysphagia, swallowing disorders, active inflammatory bowel disease, severe gastrointestinal motility disorders (e.g. untreated or severe gastroparesis, gastric contents retention, abnormal or irregular bowel motion, severe constipation), major gastrointestinal tract surgery; hypothyroidism. Pregnancy and lactation.
Obtain serum Ca, phosphorus and PTH as clinically indicated. Monitor serum chemistries including chloride and bicarbonate. Assess serum vitamin A, D, E, K and folic acid levels.
Drug Interactions
May decrease the serum concentration of ciclosporin, mycophenolate mofetil, tacrolimus and levothyroxine. Decreases the bioavailability of ciprofloxacin. May increase phosphate levels with PPIs. May reduce the absorption of vitamins A, D, E, K and folic acid. Consider separating the timing of administration with other drugs where a decrease in the bioavailability of that drug would have a significant effect on its safety or efficacy.
Action
Description: Mechanism of Action: Sevelamer is a polymer compound which acts by binding phosphate in the gastrointestinal tract thereby limiting absorption and reducing serum phosphate levels without changing the concentrations of Ca, Al or bicarbonate. Pharmacokinetics: Absorption: Not systemically absorbed. Excretion: Via faeces.